Actively Recruiting

Phase 1
Phase 2
Age: 30Years - 60Years
All Genders
NCT05558501

Intermittent Hypoxia-initiated Plasticity in Humans: A Multi-pronged Therapeutic Approach to Treat Sleep Apnea and Overlapping Co-morbidities

Led by VA Office of Research and Development · Updated on 2025-12-04

60

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

V

VA Office of Research and Development

Lead Sponsor

J

John D. Dingell VA Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

The prevalence of obstructive sleep apnea (OSA) is high in the United States and is a major health concern. This disorder is linked to numerous heart, blood vessel and nervous system abnormalities, along with increased tiredness while performing exercise likely because of a reduced blood supply to skeletal muscles. The gold standard treatment of OSA with continuous positive airway pressure (CPAP) in many cases does not lead to significant improvements in health outcomes because the recommended number of hours of treatment per night is often not achieved. Thus, development of novel treatments to eliminate apnea and lessen the occurrence of associated health conditions is important. The investigators will address this mandate by determining if repeated exposure to mild intermittent hypoxia (MIH) reduces heart and blood vessel dysfunction and tiredness/ fatigue experienced while exercise performance. The investigators propose that exposure to MIH has a multipart effect. MIH directly targets heart and blood vessel associated conditions, while simultaneously increasing upper airway stability and improving sleep quality. These modifications may serve to directly decrease breathing episodes and may also serve to improve usage of CPAP. Independent of its effect, MIH may serve as an adjunctive therapy which provides another path to reducing heart and blood vessel abnormalities that might ultimately result in improvements in exercise capacity and reverse performance fatigue in individuals with OSA.

CONDITIONS

Official Title

Intermittent Hypoxia-initiated Plasticity in Humans: A Multi-pronged Therapeutic Approach to Treat Sleep Apnea and Overlapping Co-morbidities

Who Can Participate

Age: 30Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 30 to 60 years with a BMI less than 40 kg/m2
  • Weight to hip ratio less than 1.3 in males and less than 1.2 in females
  • Diagnosed with pure or predominantly obstructive sleep apnea (AHI ≤ 100 events per hour) with average oxygen desaturation of 85% or higher
  • Newly diagnosed and not previously treated with CPAP
  • Diagnosed with hypertension, either untreated or unsuccessfully treated with one medication
  • Hypertension defined by American Heart Association 2018 criteria (systolic 120-129 and diastolic less than 80 mmHg, or stage I and II hypertension)
  • Pre-diabetic with HbA1C between 5.7 and 6.4% or fasting blood glucose between 100 and 125 mg/dL
  • Cholesterol levels between 200 and 239 mg/dL
  • Normal lung function and normal EKG
  • Minimal alcohol consumption (less than 2 oz per night)
  • Females studied at similar points in their menstrual cycle
Not Eligible

You will not qualify if you...

  • Blood pressure greater than 160/110 mmHg
  • Use of any medications except one prescribed for resistant hypertension
  • Presence of other known diseases such as pulmonary hypertension
  • Use of sleep-promoting supplements including melatonin
  • Night shift workers or recent travel across time zones
  • Pregnant females

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, United States, 48201-1916

Actively Recruiting

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Research Team

J

Jason H Mateika, PhD MS BS

CONTACT

S

Shipra Puri

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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